Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required)

This Funding Opportunity Announcement encourages the submission ofpilot and feasibilityclinical trialsconducted in humans that will lay the foundation for larger clinical trials related to the prevention and/or treatment of diseases and conditions within the mission of NIDDK. The program will support small, short-term proof-of-concept clinical trials in humans to acquire preliminary data regarding the effects of the intervention, as well as feasibility data related to recruitment and retention, and study conduct. Applications for clinical trials submitted under this FOA should have clearly described aims and objectives, and have a high likelihood that the trial findings will lead to more definitive, hypothesis-driven trials to improve understanding, diagnosis, prevention or treatment of the diseases studied and have the potential to impact clinical practice and/or public health.Preliminary data regarding intervention efficacy are not required.

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.